This single-arm phase 2 trial investigates whether a single high-dose radiotherapy treatment can safely treat men whose prostate cancer has come back in a small number of lymph nodes in the pelvis or abdomen after curative treatment. Participants receive one fraction of 24 Gy delivered with MR-guided stereotactic body radiotherapy (SBRT), which uses MRI to visualise the tumour and surrounding organs during treatment. The main goal is to assess safety (severe side effects). The trial also evaluates local tumour control, longer-term side effects, time until hormone (androgen deprivation) therapy is needed, survival, and quality of life. The trial aims to enrol 48 patients.
Age ≥ 18 years
Signed informed consent
Histologically proven initial diagnosis of adenocarcinoma of the prostate
ECOG performance status 0-2
Medical contraindications to MRI
Inability to tolerate the physical set-up required for SABR
Overlap between prior radiation fields and the current target area leading to high risk of clinically significant normal-tissue injury
Contraindications to pelvic radiotherapy (chronic pelvic inflammatory bowel disease)
Odense University Hospital
Lead sponsor
Danish Cancer Society
Collaborator